1. Field of the Invention
The invention relates to a pacifier nipple including a shaft member with a fastening portion to fix the nipple to a pacifier shield, and a head member which is located opposite the fastening portion and wide relative to the shaft member.
Furthermore, the invention relates to a pacifier comprising such a pacifier nipple.
2. Prior Art
ECC caries (early childhood caries) is the main type of caries affecting the first teeth of infants under the age of three. An infant may develop caries already at the age of seven months. Investigations have revealed that the use of bottle food promotes the growth of streptococcus and lactobacillus, both being organisms that are involved in the development of caries; yet, infants will exhibit lower overall numbers of bacteria and streptococci, if nipples that do not serve food ingestion, e.g., pacifier nipples are used for soothing. When ingesting food, e.g., milk or liquid pap, the food in the infant""s mouth will act as a nutrient for organisms, thus promoting their growth and the formation of caries. By contrast, if an infant sucks a pacifier nipple, an elevated amount of saliva will collect in the infant""s mouth, thus reducing the number of bacteria, streptococci, etc., and also reducing the risk of,caries formation.
However, due to the position of the salivary glands in the mouth, the gravity and the type of the saliva flow in the mouth of an infant, a relatively small amount of saliva reaches the infant""s teeth according to investigations that have led to the present invention, so that bacteria colonies may exactly grow there relatively undisturbed, leading to ECC caries and, in particular, the baby bottle syndrome (tooth decay).
U.S. Pat. No. 5,275,619 A describes a pacifier comprising an externally smooth nipple, said nipple having a shaft member and a wider head member. Ribs are provided in the head member on its internal side to reinforce the nipple. That nipple (and comparable nipples according to the prior art) only poorly stimulates the production of saliva and, in particular, has the drawback of not ensuring a saliva flow towards the teeth.
DE 197 01 969 A1, in turn, discloses a nipple comprising a hollow-cylindrical shaft provided with nodules. Those nodules, on the one hand, are to promote the blood flow through the jaws and the support of tooth formation and, on the other hand, are to provide an alleviating effect during teething in the manner of a teething ring. This does neither result in the stimulation of saliva production nor in an (increased) saliva flow to the tooth region.
Thus, it is the object of the invention to provide a pacifier nipple of the initially defined kind, which stimulates intensive saliva production and ensures a saliva flow to the teeth in order to obtain an optimum mouth flora also in the tooth region.
The pacifier nipple according to the invention, of the initially defined kind is characterized in that the head member, on its external side, comprises at least one thickened region forming at least one raised part, and that at least one saliva flow channel is provided in the thickened region. A pacifier nipple designed in this manner ensures that during sucking the thickened region provided on the external side of the head member, i.e. the at least one raised part, as a xe2x80x9csaliva stimulating elevationxe2x80x9d massages the interior of the mouth and, in particular, the region of the saliva glands so as to strongly stimulate the production of saliva. Yet, the saliva does not remain in the rear mouth region, but is conducted through the saliva flow channel(s) forwardly to the teeth, where its antibacterial action becomes fully effective, thus largely reducing the formation of caries. It is feasible to provide a single saliva flow channel, yet the more saliva flow channels are provided in the thickened region the more saliva will be conducted to the teeth, and accordingly several saliva flow channels are, thus, provided in a preferred manner.
It should be noted that a nipple comprising an external rib-shaped thickening is known from U.S. Pat. No. 3,946,888 A. Those ribs, however, serve to stiffen the nipple, apart from the fact that the nipple according to U.S. Pat. No. 3,946,888 A is a bottle nipple such that the saliva, through the ingestion of food via a drinking bottle, is additionally rinsed out of the mouth and the food constitutes a nutrient for organisms. EP 0 757 909 A1 likewise describes a bottle nipple comprising peripherally extending ribs externally on the shaft, which are to cause the simultaneous movement of the suction part during the exertion of a suction force in order to ensure the cleansing of the tongue surface from food remainders. From FR 2 302 724 A, a similar bottle nipple is known, which comprises a wavy external surface to enable the nipple to expand in the longitudinal direction as a suction force is being applied. Also U.S. Pat. No. 4,623,069 A describes a similar bottle nipple, which in that case is comprised of two walls slipped one into the other. Thus are formed two chambers which serve as flexible adaptation means, offering a twice reinforced resistance against the lateral pressure during suction and biting movements. Furthermore, DE 197 16 534 A1 shows a bottle nipple comprising elevations and/or depressions on at least one of its broad sides. Again, this is a bottle nipple which is intended to be kept within the mouth only for a while during drinking and exhibits the drawbacks described above. GB 2 463 A.D. 1873, moreover, discloses a teething plate which comprises elevations and depressions of different shapes. These serve to massage the palate, to provide an enhanced support within the infant""s mouth and to grind off the teeth. That teething plate, however, does not enable a xe2x80x9cmouthfillingxe2x80x9d suction, since it is designed to be flat, thus hardly stimulating the production of saliva, nor is the saliva conducted to the teeth.
In order to ensure the optimum saliva flow to the infant""s teeth with the instant pacifier nipple, it is, moreover, favorable if the saliva flow channel extends in the direction of the shaft member. In this case, saliva flow channels may extend towards the center of the fasting portion and also obliquely towards the two sides in order to ensure a saliva flow also towards the lateral teeth.
Furthermore, it is advantageous if at least one saliva flow channel extends linearly. Thus, the saliva is conducted to the teeth rapidly and directly.
Preferably, at least one saliva flow channel extends in a wave-shaped or zig-zag-like manner. Thereby, a wider region is each covered by a single saliva flow channel which is longer than a straight-line saliva flow channel, thus ensuring even more saliva to be collected in the saliva flow channel.
A particularly favorable embodiment is characterized in that at least two saliva flow channels extending in parallel are provided. These saliva flow channels may extend both linearly and in a wave-shaped or zig-zag-like manner. If several saliva flow channels extending in parallel are provided, a constant flow of saliva in the direction towards the teeth will be ensured, the saliva being conducted not only to the central front teeth, but to the entire front region of the teeth, from where the saliva may flow on laterally.
Furthermore, it is advantageous if at least two mutually intersecting saliva flow channels are provided. Such saliva flow channels may extend, for instance, obliquely to the longitudinal axis of the nipple such that, if several saliva flow channels are provided, these will form a cross-shaped pattern. In this manner, the saliva flow is distributed uniformly over the head member of the nipple so as to ensure that all the teeth will be reached by saliva.
In all these different embodiments of the saliva flow channels, also the cross section of the respective saliva flow channel may be designed in different ways. It may, for instance, be triangular, rectangular or polygonal or round. What is important is that the saliva flow channels are easy to clean, so that undercuts are to be avoided in any event. The maximum depth possible, of the saliva flow channel(s) depends also on the thickness of the thickened region, and the width of the saliva flow channel(s) as well as the width of the thickened region between two saliva flow channels may be designed differently.
It is favorable, if the, or at least one, raised part of the thickened region is designed to be rectangular and/or triangular and/or round in cross section. The different cross-sectional shapes of these raised parts, which form local elevations to stimulate saliva production, will influence the stimulation of the saliva glands differently. In addition, the use of a specific cross-sectional shape also is a function of the sensitivity of the infant""s mouth, wherein, for instance, a triangular cross section may be used for a more insensitive mouth or a toddler""s mouth, whereas a rounded cross section is to be preferred in the event of lesions, inflammations or other sensitive sites in the mouth, or for premature infants and babies, providing for a smoother massage.
An advantageous embodiment is characterized in that different saliva flow channel configurations are provided in the thickened regions of the head member. It is, for instance, feasible to provide linear, mutually crossing saliva flow channels in a thickened region of the head member and parallely extending, wave-shaped saliva flow channels in another thickened region.
Preferably, different thickened head member regions including raised parts with differently designed cross sections are provided. In this manner, one is free to insert the nipple into the infant""s mouth upwardly in the direction towards the palate by one or the other side, by one or the other thickened region, so as to ensure different stimulations due to the different configurations of the two thickened regions, depending on the position of the nipple in the mouth. The production of saliva will be stimulated even more by such a variable stimulating effect.
Another favorable embodiment consists in that the thickness of the nipple between the bottom of each saliva flow channel and the internal surface of the nipple corresponds to the thickness between the internal and external surfaces of the nipple outside the thickened region. This embodiment offers simple manufacture, additionally ensuring an optimum wall thickness of the nipple, which may, one the one hand, be thick enough to guarantee a long service life of the nipple and an adequate depth of the saliva flow channels and, on the other hand, be thin enough to make the nipple altogether flexible to an appropriate extent.
Preferably, an elevation is provided in the vicinity of the saliva flow channel, on the end located opposite the fastening portion. This elevation stimulates the rear region of the palate to a particularly high degree, which will cause an increased saliva production.
Suitably, the pacifier nipple and/or the pacifier shield are designed in a manner that, with the pacifier in use, the raised parts of the thickened regions are located topside and/or bottomside within the mouth, thus rendering saliva production particularly efficient. This will be reached, for instance, if the pacifier shield is designed to be oval or lemniscate-shaped (cf., e.g., U.S. Pat. No. 5,403, 349 A) such that the pacifierxe2x80x94even with a nipple having a circular cross sectionxe2x80x94will be taken into the mouth with one or the other side always directed upwards, but never directed transverse, since the shield predefines the position of the nipple in the mouth.
A particularly favorable nipple is provided in that it has an oval cross sectionxe2x80x94as known per se. Thus, the position of the nipple in the mouth is predetermined by the shape of the nipple: The xe2x80x9cflatxe2x80x9d sides of the nipple forming the upper and lower sides of the nipple in the mouth. In this case, only one flat side may comprise at least one thickened region, yet a configuration comprising thickened regions on both flat sides of the nipple is more favorable. In this manner, the position of the nipple in the infant""s mouth is not critical in terms of upper and lower sides, a strong flow of saliva towards the teeth being ensured at any time.
It is of advantage if a smooth edge zone surrounding the thickened region is provided. Enlargements in the edge zone, in particular with elliptical nipple cross sections will, in fact, not cause any intensification, but surprisingly facilitate the biting through of the nipple, as studies have demonstrated.
It is, of course, possible to impart elongate, round, stellar or any other shapes on the surface of the thickened region, whereby one of the regions of the head part again may have another thickened region surface shape than another region.
Preferably, the pacifier nipple is made of silicone, latex, rubber or synthetic materials. In terms of manufacture, it is easier to produce the whole pacifier including its enlargements of the same material, yet it is also feasible to make a nipple of one material and a thickened region in the form of a coat, of another material. The choice of the respective material also is a function of the desired thickness of the nipple, with health aspects having to be taken into account, anyway.
Furthermore, the invention provides a pacifier including a pacifier shield, which comprises a pacifier nipple as defined above. In this case, the nipple is attached inside the pacifier shield by its fastening portion in a conventional manner, for instance, by clamping, gluing, etc.